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Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00102934
First received: February 4, 2005
Last updated: September 16, 2008
Last verified: September 2008

February 4, 2005
September 16, 2008
March 2003
December 2005   (final data collection date for primary outcome measure)
HIV viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
HIV viral load
Complete list of historical versions of study NCT00102934 on ClinicalTrials.gov Archive Site
Frequency of HIV-specific T cells [ Time Frame: Thoughout study ] [ Designated as safety issue: No ]
Frequency of HIV-specific T cells
Not Provided
Not Provided
 
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus.

This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Enfuvirtide-intensified HAART
90 mg tablet taken orally twice daily
Other Names:
  • T-20
  • Fuzeon
Experimental: 1
Participants will receive enfuvirtide for 6 months
Intervention: Drug: Enfuvirtide-intensified HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
March 2009
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV viral load of more than 1000 copies/ml
  • On stable antiretroviral therapy
  • Have multidrug resistance

Exclusion Criteria:

  • Require immunomodulatory drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102934
5R21AI055273-02, Protocol 834, 5R21-AI055273-02
Not Provided
Steven G. Geeks, MD, Department of Medicine, University of California - San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Steven G. Deeks, MD Department of Medicine, University of California - San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP